K162741 is an FDA 510(k) clearance for the AxoGuard Nerve Connector. This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).
Submitted by Cook Biotech Incorporated (West Lafayetta, US). The FDA issued a Cleared decision on October 31, 2016, 31 days after receiving the submission on September 30, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.
| 510(k) Number | K162741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2016 |
| Decision Date | October 31, 2016 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXI — Cuff, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5275 |